GTx, Inc. (NASDAQ: GTXI) announced today there will be two scientific poster presentations on the effects of enobosarm, a selective androgen receptor modulator (SARM), on improving physical function and quality of life in middle aged and elderly cancer patients. The posters will be displayed on October 26th and 27th, 2012, at the 12th Meeting of the International Society of Geriatric Oncology to be held at the Manchester Central Convention Centre in Manchester, United Kingdom. Ryan P. Taylor, PhD, GTx’s Associate Director of Medical Affairs, will present data from the company’s Phase IIb clinical study of enobosarm, providing evidence that enobosarm may play an important role in the management of cancer patients with muscle wasting by improving physical function and quality of life, regardless of baseline weight loss or age.
The first poster presentation will present data exploring patient response to treatment by grouping subjects according to their baseline weight loss (less or greater than 5% in the 6 month period prior to randomization), and the age of the patient (above and below the median age of 66 years). Of the 159 subjects randomized into the study, 103 had physical function (by stair climb test) assessed at both baseline and following 16 weeks of treatment and 24% of these subjects had lost less than 5% of weight. Significant improvement in physical function was observed in enobosarm treated subjects, while placebo subjects failed to improve, regardless of baseline weight loss or age.
The second poster presentation will present data indicating that patients, who responded to treatment during the enobosarm clinical study (>10% improvement in stair climb power), significantly increased three separate measures of quality of life, regardless of age. Quality of life questionnaires from 95 of the 159 subjects randomized into the study were analyzed to determine if there was an association between improvement in stair climb power (the physical function test assessed during the clinical study) and quality of life. Generally, a 5% increase in physical function from baseline is regarded as a minimal clinically meaningful change in physical function, while a 10% increase in physical function from baseline is thought to be a substantial clinically meaningful change. Subjects who showed improvements in stair climb power also were found to have improvements in quality of life, and subjects with the greatest stair climb improvement also had the greatest measured improvements in quality of life.
Enobosarm is a SARM which binds to the androgen receptor and is designed to deliver the beneficial effects of androgens while minimizing unwanted clinical side effects. GTx conducted its Phase IIb clinical study of enobosarm in 159 cancer patients (average age of 66 years) in 35 sites in the United States and Argentina. Participants were randomized to receive placebo, 1 mg or 3 mg oral tablet of enobosarm once daily for 16 weeks. Average reported weight loss prior to entry among all subjects was 8.8%, and subjects were allowed to have standard chemotherapy during the trial. The drop-out rate during the trial was 33%. The study met its primary endpoint of absolute change in total lean body mass (muscle) compared to placebo after 16 weeks of treatment.
GTx is conducting two pivotal Phase III clinical trials (POWER 1 and POWER 2) in the United States, Europe and South America, evaluating a once daily 3 mg dose of enobosarm for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. More information about these two clinical studies can be found at www.gtxclinicaltrials.com.
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules for the treatment of cancer, cancer supportive care, and other serious medical conditions.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to GTx's clinical trial for enobosarm (also known as Ostarine® or GTx-024). GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials being conducted by GTx may not be completed on schedule, or at all, or may otherwise be suspended or terminated; or (iv) that GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2012 contains under the heading, "Risk Factors", a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.Business Wire
Last updated on: 08/10/2012